Title: Inspection - BCA Process for Finalization of Inspection Reports
Release Date: 01 Apr 2020 Author: BRASMUSSEN Document Number: CVB-WI-0121.02
CONTROLLED//PROPIN//BASIC

c. The BCA will
i. Mail original signed report and cover letter to the firm.
ii. Follow internal documented procedures for the checking of the mail prior
to it being sealed and sent out — see CVB-WI-0118, CVB-IC Mail/Filing.
iii. Keep certified receipt. Verify receipt by the firm. Await green Certified
Receipt card’s return.
iv. Record the date the green Certified Receipt card was received by the firm
in the ML

e Moving the ML out of “Finalization” triggers LSRTIS to move the record out
of “Pending Finalization” on the Inspection dashboard.

Consistency Items for Inspection Reports

1. Observations are to be written in past-tense; however, references to liaisons or
personnel responsibilities should be written in present-tense.

2. When using CVB-TEM-0018, Inspection — Report, the location of the firm listed on
the cover page should spell out the name of the state rather than the abbreviation. No zip
code should be listed in this section.

3. Double space between items within the report and triple space between categories.

4. When referencing 2007 and 2008 forms within the report, the plural should be on
“2008s” and “2007s”, not “Forms.”

5. Spell out acronyms the first time they are used in the report with the initials in
parentheses directly following. The initials may be used after that within the report
(example: Veterinary Services (VS) Memorandum).

6. The first time a product is referenced in the report, the true name must be included
along with the product code. After that, only the product code needs to be used
(example: Code 19A5.21).

CVB-WI-0121.02 Page 3 of 3

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Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Inspection - BCA Process for Finalization of Inspection Reports

Release Date: 01 Apr 2020 Author: BRASMUSSEN Document Number: CVB-WI-0121.02

Health Inspection
Service

Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(15) 337-6100

CONTROLLED//PROPIN//BASIC

Inspection - BCA Process for Finalization of Inspection Reports

Document Number: CVB-WI-0121 Revision: 02
Previous Number: ICWI0115.03

Vault: CVB-Released

Section/Area: CVB-WI-IC

Effective Date: 01 Apr 2020

Notes:

Printed by: CRRYAN on 01 Apr 2020, 02:30:53 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Inspection - BCA Process for Finalization of Inspection Reports
Release Date: 01 Apr 2020 Author: BRASMUSSEN Document Number: CVB-WI-0121.02
CONTROLLED//PROPIN//BASIC

Inspection - BCA Process for Finalization of Inspection Reports

Source Document: CVB-SOP-0036, Post-Inspection Activities
Inspection Reports are routed through the Mail Log (ML) system.

Related Work Instructions
e CVB-WI-0139, Mail Work Flow for Correspondence for Inspection and
Compliance: Biologics Specialist Review
¢ CVB-WI-0136, Routing Inspection Reports — For Specialist

A. Prior to finalizing an inspection report in the ML

1. Ensure the inspection has moved from “Pending Report” to “Pending Finalization”
in the LSRTIS — IC — Inspections Dashboard screen. Moving forward and finalizing
the report in the ML without having the inspection record in “Pending
Finalization” creates errors in the system.

e If it has not moved to “Pending Finalization”, the Specialist may not have
entered action items and/or linked the ML to the inspection record. (Note: the
Specialist may NOT move an inspection report to the IC Inbox Pool until the
ML has been linked to the inspection record).

2. The ML Workflow Log should indicate Section Leader (SL) Inspection and
Compliance (IC) review as approved, “Yes,” prior to finalization by the Biologics
Compliance Assistants (BCAs). When there is an Acting SL, there may be a comment
indicating the policy review has been done. This is sufficient.

B. Inspection Report in IC Inbox Pool

1. Reports are to be finalized on a first-in, first-out basis. BCAs self-assign the
oldest inspection report to their queue for review and formatting. The ML will move
to Finalization (IC) automatically after an Inspection Report is self-assigned.
IMPORTANT: Make sure the activity in your queue at this point is Finalization (IC).
If it isn’t, the ML was not coded correctly and the previous reviews did not catch this.
Please inform the SL who did the Section Leader Review (IC).

If the ML isn’t coded as Type “Inspection” and Subtype “Inspection Report” it will
move into your queue in Review (BCA) activity. If this happens, do the following
steps:

a. Open ML and Click on Edit Mail Item

b. Under Submission Subtype find “Inspection Report” and click on Add

c. Click on Update

d. Move Forward the ML item and choose Activity, Finalization (IC) and select

yourself.
Now it should be in your queue for finalization. This is important for coding that
moves the inspection report in LSRTIS and generates ML for Serious Actions
automatically.

CVB-WI-0121.02 Page | of 3

Printed by: CRRYAN on 01 Apr 2020, 02:30:53 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Inspection - BCA Process for Finalization of Inspection Reports
Release Date: 01 Apr 2020 Author: BRASMUSSEN Document Number: CVB-WI-0121.02
CONTROLLED//PROPIN//BASIC

2. Any changes to the inspection report should be discussed with the Team
Leader/author prior to finalization. If the Team Leader is out, changes can be
discussed with the Section Leader, Inspection.

C. Finalize report and cover letter

1. After finalizing, convert the Word documents (inspection report and cover letter)
into pdf format
2. Attach pdf documents to ML
a. Cover letter is identified as Outgoing Correspondence
b. Inspection Report is identified as Outgoing Inspection Report
3. Add all applicable EM Notifications to ML
CVB Director
PEL Director
IC Director
IC — SL Inspection
IC — Supervisor of the Team Leader
PEL Reviewer(s)
Inspection Team Members
4. If firm is not portal enabled
a. Make hard copy of report and cover letter for Team Leader’s signature
b. Prepare certified envelope for mailing report and cover letter to firm
5. Complete Submission Response on Info tab of ML
a. Date of letter
b. Date mailed
c. Shipment type — Portal or Certified Mail
d. Shipment tracking number; only if documents are sent certified mail
e. Put inspection report and cover letter in purple folder to Specialist for
signature

D. Move the ML item to Specialist for signature

1. If firm is portal enabled, Specialist will
a. Doa final review of documents for any final corrections
b. Electronically sign inspection report and cover letter
c. Move the ML item to SL for Final Authorization
d. The SL will review and move the ML to Records Management (RM)
2. If firm is not portal enabled
a. The Specialist will
i. Doa final review of documents for any final corrections
ii. Sign original inspection report and cover letter
iii. Move ML to SL for Final Authorization
b. The SL will
i. Move the ML item to the BCA under the “Certified Receipt” activity
ii. Give the signed hard originals back to the BCA to be mailed

CVB-WI-0121.02 Page 2 of 3

Printed by: CRRYAN on 01 Apr 2020, 02:30:53 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100